Our services

An experienced medical writing consultancy

Scinopsis is an experienced medical writing consultancy providing high quality documents for the pharmaceutical, biotechnology and medical device industries.

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CLINICAL TRIALS DOCUMENTATION

Protocols and informed consent forms
Clinical study reports
Patient narratives
Investigator brochures
Investigational medicinal product dossiers (IMPD)
Registry postings
Lay summaries

REGULATORY DOCUMENTS

Briefing packages
NDA/MAA/CTD clinical modules
Responses to EMA/FDA questions
Integrated summaries of safety & efficacy
PIP/PSP & waivers
Risk management plans
Orphan designation applications
Core value dossiers

MEDICAL COMMUNICATIONS

Publications
Literature reviews
Systematic reviews
Slides, posters & abstracts
Conference reports
Medical education materials

MEDICAL DEVICES

Clinical investigation plans
Clinical investigation reports
Clinical evaluation reports
Medical device publications

No problems, only solutions

OUR EXPERTS

Highly qualified scientists (PhD or MD)
Native English (or equivalent)
International team located in France and the UK
Expertise in a wide range of document types and therapeutic areas
Expert writing and communication skills

QUALITY IS OUR TOP PRIORITY

Robust quality management system
Successful client audits
Full compliance with EMA, FDA and ICH guidelines
In-house document review and quality control
Excellent reputation in the industry
Preferred-provider for several customers
Many highly satisfied customers